Director, Vigilance Operations

Nicolas Martin joined Voisin Consulting Life Sciences (VCLS) in 2009 and participates in the design and implementation of Regulatory Strategies for the Development of Drugs and Innovative Medicinal Products and in the set up and management of Pre- and Post-Approval Vigilance systems, both for Clinical Trial Sponsors and Marketing Authorisation Applicants / Holders, and for various type of health care products (incl. medicinal products).

Nicolas co-heads the Vigilance Operations, to support in managing the group strategy and resources, overseeing QA activities, business development and knowledge management.

Nicolas is more specifically involved in vigilance activities such as Individual Case Safety Reports (ICSRs) management, EudraVigilance Registration (company and product), Expedited (electronic and paper), product registration in the XEVMPD and Periodic Safety reporting for all types of products (drugs, biologics, gene & cell therapy etc.) and Medical Devices, interactions with Regulatory Authorities. Nicolas was a key player in the safety database validation at Voisin Consulting Life Sciences. He is the acting Deputy QPPV on various post-marketing vigilance activities and is also involved in the safety database administration and in charge of maintaining the validated safety database.

Nicolas is also involved in the preparation, submission and management of Clinical Trial Applications in Europe.

Nicolas gained previous international experience as part of his Master Degree while completing an internship at the University of Toronto in the Faculty of Medicines/Center for Addiction and Mental Health. He also gained experience in the field of Molecular Biology during another internship at the Molecular and Cellular Institute of Pharmacology – CNRS (French National Center for Scientific Research).

Nicolas obtained his Master’s Degree (Engineering) in Biotechnology and Pharmacology from Polytech’Nice-Sophia in Sophia-Antipolis, France.

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